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Philips Azurion Image Guided Therapy Systems
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MEDICAL DEVICE RECALLMODERATE

Philips Azurion Image Guided Therapy Systems

Philips is recalling various Azurion systems due to potential mechanical wear in the Float Tabletop control module affecting table movement.

What to do

Contact your local Philips representative or service engineer to schedule a mandatory inspection and repair of the Float Tabletop control module.

Recalled
Listed
Updated
Recall No.
Z-2225-2026
Agency
FDA
Firm
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Recall ID
98812
Status
ONGOING

Recall at a glance

Quantity recalled
5,537 units

Why it was recalled

Philips is recalling various Azurion image-guided therapy systems because mechanical wear of the Float Tabletop control module can impact longitudinal and transverse table movements. The affected systems were distributed nationwide.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductUDI-DI
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226,00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275, 00884838085275
Philips Azurion systems not configured with an optional auxiliary pan handle. Includes the below product descriptions and corresponding model numbers. 1. Azurion 3 M12; Model Numbers: 722063, 722229. 2. Azurion 3 M15; Model Numbers: 722222, 722064, 722280, 722230. 3. Azurion 5 M12; Model Numbers: 722227, 722231. 4. Azurion 5 M20; Model Numbers: 722228, 722232, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225, 722235. 6. Azurion 7 B20; Model Numbers: 722068, 722226, 722236. 7. Azurion 7 M12; Model Numbers: 722078, 722223, 722233. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722234, 722282.722063, 00884838085275, 146, 102, 144, 119, 120, 121, 110, 103, 101, 143, 116, 141, 115, 137, 150, 128, 129, 139, 130, 154, 100, 106, 135, 123, 133, 148, 722064, 00884838085282, 513, 162, 161, 297, 169, 131, 479, 190, 359, 220 (+1414 more, see the official notice)

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification